About this role
About the Role
Join Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization that defines favorable quality characteristics and optimizes analytical tools to guide development. The Pivotal PD organization focuses on developing and commercializing robust manufacturing processes across modalities, including synthetic medicines, monoclonal and bispecific antibodies, bispecific T-cell engagers, and live oncolytic viruses. Located at our Thousand Oaks, CA office, the PD Senior Scientist will provide strategic analytical leadership as an Attribute Sciences team lead to teams developing commercializable manufacturing processes and collaborate with Drug Substance and Drug Product colleagues. What You'll Do
- Supervise and provide technical support for a team that provides analytical support for late stage product development
- Act as an Attribute Sciences Team lead for a program in pivotal clinical process development, responsible for all analytical work to support the program
- Define the analytical target profile (ATP) for methods used to monitor product quality. Based on the ATP, oversee the development, qualification, remediation, and transfer of analytical methods to Quality Control
- Manage activities at contract manufacturing and testing sites
- Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.